Monthly Archives: November 2018

I was all ready to explain away a short newsletter based on the long Thanksgiving holiday weekend in the US. But no, this is a long one, with lots of warning letter action and an EU report of GMP non-compliance. Four drug warning letters, including one to Mylan’s Morgantown WV site, and one to a device manufacturer were posted [...]

This week has one guidance from FDA and two from EMA. The one addressing pharmaceutical water quality is important for everyone to read, even though it is a draft. IMDRF published three final documents, HPRA and New Zealand each published one. We saw the usual collection of non-guidance documents from FDA, MHRA, EMA and others. FDA published one device [...]

From the fire area of Thousand Oaks CA, the firefighters are loved here and with good reason! Truly exceptional people to whom we owe our gratitude. A few guidance documents from FDA, EMA and CDSCO. Some good reading. The usual group of non-guidance from the FDA, EMA, MHRA, HPRA and TGA this week. Enforcement again this week is slow [...]

A bit of a slow week on the guidance front, only three documents from the FDA and none from EMA or other jurisdictions. On the non-guidance front, we have a collection from FDA, MHRA, TGA and HPRA, nothing from EMA this week. Enforcement includes GCP warning letters, four warning letters to device manufacturers that are located outside the US [...]